During the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting in May, Greg Simon and Steve George sat down to discuss challenges and lessons learned from NIH Collaboratory Trials on healthcare system and patient engagement.

Simon said it is key for embedded pragmatic clinical trials to build long-term relationships with healthcare systems, starting with finding out what are the needs of the healthcare system, the clinicians, and the patients they care for, and then building trials that address the questions they care about.

But healthcare systems change rapidly, which can lead to challenges, such as turnover at different levels of leadership, including the top level of the healthcare system, the clinic management level, and the provider level.

“It is important for clinical trial investigators to think about how do I form relationships with those people who are likely to be here for a while? How do I form relationships at multiple levels with different people,” Simon said.

With patient engagement, George said the challenges have evolved with the NIH Collaboratory Trials. When the NIH Collaboratory started, the initial challenge was whether to do patient engagement or not. Today, patient engagement is more of an expectation for trials, so the questions have become more nuanced, George said. Now trials must consider at what phase of the trial are you going to do patient engagement; who are you going to involve; and are you going to do it throughout the trial?

The NIH Collaboratory’s Living Textbook includes a new chapter on Patient Engagement to help investigators think through these questions.

“One of the most effective resources is the reporting and the information sharing across trials. There are a lot of models of how this has been done. There are a lot of models of how I would do it differently if I did it again, and I think that open sharing is very powerful for people to see because people like examples,” George said.

Simon, a senior investigator at Kaiser Permanente Washington Health Research Institute, is the chair of the NIH Collaboratory’s Health Care Systems Interactions Core and a member of the Coordinating Center leadership team. George is the Laszlo Ormandy Distinguished Professor of Orthopaedic Surgery at Duke University.